SPRYCEL may cause serious side effects, including low blood cell counts, bleeding problems, fluid retention, heart problems, pulmonary arterial hypertension, severe skin reactions, tumor lysis syndrome, and slowing of growth and development in children. Side effects of SPRYCEL that are considered most common in adults include: diarrhea, headache, skin rash, shortness of breath, tiredness, nausea, and muscle pain. Side effects of SPRYCEL that are considered most common in children include: headache, nausea, pain in hands or feet (extremities), diarrhea, skin rash, and stomach (abdomen) pain. This is not a complete list of all side effects with SPRYCEL. Tell your healthcare provider if you have any side effects while taking SPRYCEL.

Please read more information about potential side effects with SPRYCEL below.

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Important Facts About SPRYCEL® (dasatinib)

This is a summary of important information that patients need to know about SPRYCEL. Your healthcare team can work with you to help answer any questions you may have about SPRYCEL.

Keep this document in a safe place, so you can refer to it before and during treatment.

What is SPRYCEL?

Adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including GLEEVEC® (imatinib mesylate)

Adults with Ph+ acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment

Children with Ph+ CML in chronic phase

Example SPRYCEL tablet. Tablet is not actual size.

Tablets are white to off-white, with “BMS” appearing on one side. These letters may be followed by a number indicating the strength of the tablet, in milligrams. In addition, an identification number will be marked on the other side. Size and shape may vary by dose.
Tablets are taken by mouth.

What should I discuss with my healthcare provider before starting SPRYCEL?

Talk to your healthcare provider about all of your medical conditions, including if you have any of these medical conditions:

problems with your
immune system

heart problems, including a
condition called congenital
long QT syndrome

low potassium or low
magnesium levels in your blood

lactose (milk sugar) intolerance

problems with your immune system

heart problems, including a condition called congenital long QT syndrome

low potassium or low magnesium levels in your blood

lactose (milk sugar) intolerance

Tell your healthcare provider if you are:

Pregnant or plan to become pregnant. SPRYCEL® (dasatinib) can harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment and for 30 days after your final dose of SPRYCEL. If you become pregnant or think you may be pregnant during treatment with SPRYCEL, talk to your healthcare provider right away.

Breastfeeding or plan to breastfeed. It is not known if SPRYCEL passes into your breast milk. You should not breastfeed during treatment and for 2 weeks after your final dose of SPRYCEL.

Females who are pregnant should not handle crushed or broken SPRYCEL tablets.

Tell your healthcare provider about all the medicines you take, including:

prescription and
over-the-counter medicines

vitamins

herbal supplements

antacids

If you take an antacid medicine, take it 2 hours before or 2 hours after your dose of SPRYCEL.

SPRYCEL may interact with other medicines you are taking. This can change the relative effectiveness of SPRYCEL, or cause unwanted side effects.

During treatment with SPRYCEL, make sure you also talk to your healthcare provider before you begin to take anything new. Your healthcare provider can help identify any potential interactions and help find alternatives.

Tell your healthcare provider about all the medicines you take, including:

prescription and over-the-counter
medicines

vitamins

antacids

herbal supplements

If you take an antacid medicine, take it 2 hours before or 2 hours after your dose of SPRYCEL.

SPRYCEL may interact with other medicines you are taking. This can change the relative effectiveness of SPRYCEL, or cause unwanted side effects.

During treatment with SPRYCEL, make sure you also talk to your healthcare provider before you begin to take anything new. Your healthcare provider can help identify any potential interactions and help find alternatives.

How should SPRYCEL be taken?

Take SPRYCEL exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose of SPRYCEL or temporarily stop treatment with SPRYCEL. Do not change your dose or stop taking SPRYCEL without first talking to your healthcare provider.

Do take SPRYCEL one (1) time a day

Do take SPRYCEL with or without food, either in the morning or in the evening, at the same time each day*

Do swallow SPRYCEL tablets whole with water

*Setting an alarm clock or calendar notification is a great way to remember to take medication.

Do not cut, crush, or chew the tablets

Do not drink grapefruit juice during treatment with SPRYCEL

Do not take St. John’s wort during treatment with SPRYCEL

*Setting an alarm clock or calendar notification is a great way to remember to take medication.

What if I miss a dose of SPRYCEL?

If you miss a dose of SPRYCEL, take your next scheduled dose at your regular time. Do not take two doses at the same time. Call your healthcare provider or your pharmacist if you are not sure what to do.

What are the possible side effects of SPRYCEL® (dasatinib)?

Call your healthcare provider right away if you have any symptoms of the side effects below, or any other concerns about these side effects:

Low blood cell counts:Low blood cell counts are common with SPRYCEL and can be severe, including low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with SPRYCEL. Call your healthcare provider right away if you have any of these symptoms during treatment with SPRYCEL:

fever

any signs of infection

Low blood cell counts:Low blood cell counts are common with SPRYCEL and can be severe, including low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with SPRYCEL. Call your healthcare provider right away if you have any of these symptoms during treatment with SPRYCEL:

fever

any signs of infection

Bleeding problems: Bleeding problems are common with SPRYCEL. Sometimes these bleeding problems can be serious and lead to death. Call your healthcare provider right away if you have:

unusual bleeding or bruising of your skin

bright red or dark tar-like stools

decreased alertness, headache,
or change in speech

Bleeding problems: Bleeding problems are common with SPRYCEL. Sometimes these bleeding problems can be serious and lead to death. Call your healthcare provider right away if you have:

unusual bleeding or bruising of your skin

bright red or dark tar-like stools

decreased alertness, headache, or change in speech

Your body may hold too much fluid (fluid retention):Fluid retention is common with SPRYCEL and can sometimes be severe. In severe cases, fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your healthcare provider right away if you have any of these symptoms during treatment with SPRYCEL:

swelling all over your body

shortness of breath,
especially if this happens with low
levels of physical activity or at rest

dry cough

chest pain when taking a deep breath

weight gain

Your body may hold too much fluid (fluid retention):Fluid retention is common with SPRYCEL and can sometimes be severe. In severe cases, fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your healthcare provider right away if you have any of these symptoms during treatment with SPRYCEL:

swelling all over your body

weight gain

shortness of breath, especially if this happens with low levels of physical activity or at rest

Pulmonary Arterial Hypertension (PAH): SPRYCEL may cause high blood pressure in the vessels of your lungs. PAH may happen at any time during your treatment with SPRYCEL. Your healthcare provider should check your heart and lungs before and during your treatment with SPRYCEL. Call your healthcare provider right away if you have any of these symptoms:

shortness of breath

tiredness

swelling all over your body
(fluid retention)

Pulmonary Arterial Hypertension (PAH): SPRYCEL may cause high blood pressure in the vessels of your lungs. PAH may happen at any time during your treatment with SPRYCEL. Your healthcare provider should check your heart and lungs before and during your treatment with SPRYCEL. Call your healthcare provider right away if you have any of these symptoms:

shortness of breath

tiredness

swelling all over your body (fluid retention)

Severe skin reactions: SPRYCEL may cause skin reactions that can sometimes be severe. Get medical help right away if you have any of these symptoms:

skin reaction with fever

sore mouth or throat

blistering or peeling of your
skin or in the mouth

Severe skin reactions: SPRYCEL may cause skin reactions that can sometimes be severe. Get medical help right away if you have any of these symptoms:

skin reaction with fever

sore mouth or throat

blistering or peeling of your skin or in the mouth

Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause kidney failure and an abnormal heartbeat. Kidney failure may require the need for dialysis treatment. Your healthcare provider may do blood tests to check you for TLS

Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause kidney failure and an abnormal heartbeat. Kidney failure may require the need for dialysis treatment. Your healthcare provider may do blood tests to check you for TLS

Slowing of growth and development in children: Effects on bone growth and development in children with chronic phase CML have happened with SPRYCEL and can sometimes be severe

Slowing of growth and development in children: Effects on bone growth and development in children with chronic phase CML have happened with SPRYCEL and can sometimes be severe

Most common side effects

The most common side effects of SPRYCEL® (dasatinib) in adults include:

diarrhea

shortness of breath

muscle pain

headache

tiredness

skin rash

nausea

The most common side effects of SPRYCEL in children include:

headache

pain in hands or feet
(extremities)

skin rash

stomach (abdomen) pain

nausea

diarrhea

diarrhea

headache

skin rash

shortness of breath

tiredness

nausea

muscle pain

The most common side effects of SPRYCEL in children include:

headache

nausea

pain in hands or feet (extremities)

diarrhea

skin rash

stomach (abdomen) pain

SPRYCEL may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of SPRYCEL. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your healthcare provider for medical advice about side effects.

You may report side effects to the FDA by calling 1-800-FDA-1088.

How do I store SPRYCEL?

SPRYCEL tablets should be stored at room temperature between 68°F to 77°F (20°C to 25°C).

Ask your healthcare provider or pharmacist about the right way to throw away outdated or unused SPRYCEL.

Wear latex or nitrile gloves when handling tablets that have accidentally been crushed or broken.

Females who are pregnant should not handle crushed or broken SPRYCEL tablets.

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